Takeda Pharmaceutical (US)
Senior Medical Director, Clinical Science, Gastrointestinal and Inflammation The
Takeda Pharmaceutical (US), Cambridge, Massachusetts, us, 02140
Senior Medical Director – GI & Inflammation – Rheumatology
Cambridge, MA – Join Takeda, a values‑led company committed to better health.
OBJECTIVES
Lead and drive strategy for global clinical development for assigned pipeline compounds.
Lead a multi‑disciplinary, multi‑regional matrix team through complex decisions.
Apply clinical/medical decision making to clinical development issues and influence senior leadership.
ACCOUNTABILITIES Clinical Development team participation and leadership
Lead Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team.
Establish and drive Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
Drive clinical science activities relating to the preparation/approval of synopses, protocols and the conduct of clinical studies. Serve as an advisor to other clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies. Present study conclusions to Management and determine how individual study results impact the overall compound strategy.
Interpret data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assess overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversee non‑medical clinical scientists with respect to assessment of these issues.
Makes final decisions regarding study conduct related to scientific integrity.
External Interactions
Directs activities involved in interactions with regulatory authorities/agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
Due Diligence, Business Development and Alliance Projects
Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in‑licensing opportunities. Assess scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
Leadership, Task Force Participation, Upper Management Accountability
Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross‑functional teams, as appropriate.
Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conduct performance reviews and drive goal setting and development planning.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health‑related consulting company, or biomedical/clinical experience within academia (or a combination of the above).
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
NDA/MAA/Submission experience preferred.
Management experience.
Board‑certified in rheumatology preferred.
Skills
Superior communication, strategic, interpersonal and negotiating skills.
Ability to proactively predict issues and solve problems.
Ability to drive decision‑making within a multi‑disciplinary, multi‑regional, matrix teams.
Diplomacy and positive influencing abilities.
Knowledge
Therapeutic area knowledge relevant to mechanism of action.
Regional/global Regulatory requirements.
Emerging research in designated therapeutic area.
TRAVEL REQUIREMENTS
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 15 – 25% travel.
Compensation and Benefits Summary
U.S. Base Salary Range: $257,600.00 – $404,800.00.
Eligible for short‑term and long‑term incentive plans, 401(k) with match, health insurance, paid volunteer time off, company holidays, and well‑being benefits.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr
OBJECTIVES
Lead and drive strategy for global clinical development for assigned pipeline compounds.
Lead a multi‑disciplinary, multi‑regional matrix team through complex decisions.
Apply clinical/medical decision making to clinical development issues and influence senior leadership.
ACCOUNTABILITIES Clinical Development team participation and leadership
Lead Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team.
Establish and drive Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
Drive clinical science activities relating to the preparation/approval of synopses, protocols and the conduct of clinical studies. Serve as an advisor to other clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies. Present study conclusions to Management and determine how individual study results impact the overall compound strategy.
Interpret data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assess overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversee non‑medical clinical scientists with respect to assessment of these issues.
Makes final decisions regarding study conduct related to scientific integrity.
External Interactions
Directs activities involved in interactions with regulatory authorities/agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
Due Diligence, Business Development and Alliance Projects
Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in‑licensing opportunities. Assess scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
Leadership, Task Force Participation, Upper Management Accountability
Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross‑functional teams, as appropriate.
Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conduct performance reviews and drive goal setting and development planning.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health‑related consulting company, or biomedical/clinical experience within academia (or a combination of the above).
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
NDA/MAA/Submission experience preferred.
Management experience.
Board‑certified in rheumatology preferred.
Skills
Superior communication, strategic, interpersonal and negotiating skills.
Ability to proactively predict issues and solve problems.
Ability to drive decision‑making within a multi‑disciplinary, multi‑regional, matrix teams.
Diplomacy and positive influencing abilities.
Knowledge
Therapeutic area knowledge relevant to mechanism of action.
Regional/global Regulatory requirements.
Emerging research in designated therapeutic area.
TRAVEL REQUIREMENTS
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 15 – 25% travel.
Compensation and Benefits Summary
U.S. Base Salary Range: $257,600.00 – $404,800.00.
Eligible for short‑term and long‑term incentive plans, 401(k) with match, health insurance, paid volunteer time off, company holidays, and well‑being benefits.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr